Multiple MyelomaEarly Phase 1NCT06385652
PET Imaging Study of 68Ga-NB381 in Multiple Myeloma
A Early Phase 1 study testing 68Ga-NB381 in people with Multiple Myeloma, run by Peking University First Hospital at 1 site in China.
Trial summary
Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- 68Ga-NB381
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suspected of multiple myeloma who are scheduled to undergo bone marrow aspiration or tissue biopsy within the next 3 months; aged between 18 and 90 years; participants must fully understand and voluntarily participate in this study, and sign an informed consent form; must be able to independently comply with the examination procedures.
- Confirmed symptomatic multiple myeloma patients; aged over 18 years; participants must fully understand and voluntarily participate in this study, and sign an informed consent form; must be able to independently comply with the examination procedures.
Who cannot join
- Pregnant women
- Individuals who cannot understand the examination process or are unable to cooperate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Ronghui Yu, Master, +8613466379791, kyc@bjmu.edu.cn
Lei Kang, MD
About this study
Official title: Clinical PET Imaging Evaluation of 68Ga-NB381 Probe in Multiple Myeloma
Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.
Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies.
Read the detailed description
Multiple myeloma (MM) commonly occurs in the elderly and often remains undetected until it reaches an advanced stage. With the aging population in China, the incidence of MM is on the rise, now surpassing that of acute leukemia. Clinically, MM is characterized by bone destruction and lacks specificity; diagnosis primarily relies on bone marrow biopsies that detect an increase in clonal plasma cells, which are invasive and can yield false-negative results if the biopsy site is improperly selected. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for MM.
As the incidence of malignant tumors in China continues to increase, so does the clinical demand for radiopharmaceuticals. Addressing the limitations in the targeting of 18F-FDG in PET imaging, the development of new targeted nuclear medicine molecular probes is of significant academic value and clinical importance, particularly in monitoring the therapeutic effects of the CD38-targeted nanobody NB381, which offers unique advantages. This project uses a nanobody with high affinity for CD38 as the targeting moiety for the radiopharmaceutical, exploring the diagnostic efficiency of 68Ga-NB381 in patients with MM exhibiting high CD38 expression. This not only provides a basis for the early diagnosis of MM but also allows for the formulation of effective precision treatment strategies based on the CD38 expression profile in MM patients.
68Ga-NB381, a new CD38-targeted molecular probe labeled with 68Ga, can be used for the diagnosis and research of various malignancies expressing high levels of CD38, including MM. The probe is conjugated with 68Ga3+ using TOHP as a bifunctional chelator, with a simple labeling process that does not require purification, offering high in-vivo stability and significant radioactive accumulation in tumor sites in mouse models, resulting in superior imaging outcomes. This project will complete the automation of the 68Ga-NB381 labeling process and conduct quality control studies on the resulting radiopharmaceutical injection solution, establishing quality standards for this new PET probe and laying the foundation for its clinical translation in China. The project aims to provide 68Ga-NB381 PET/CT imaging studies to support the early diagnosis of CD38 high-expression malignancies, the formulation of treatment plans, and the assessment of therapeutic efficacy.
- Conditions
- Multiple Myeloma
- Being tested
- 68Ga-NB381
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NB381Drug
Also called 18F-FDG
Lei Kang from Peking University First Hospital and Bing Jia's team from the School of Basic Medical Sciences at Peking University have developed a targeted CD38 nanobody sequence using genetic engineering technology. They have optimized its structure, functionalized it with labeling, and conducted imaging and other evaluations, ultimately producing the CD38-targeted nuclear medicine small molecule diagnostic and therapeutic agent-68Ga-labeled nanobody NB381. The post-labeling quality control of the drug meets clinical trial requirements with a radiochemical purity (PCR) greater than 98% and in vitro stability not less than 90%.
Preliminary PET imaging results of 68Ga-NB381 indicate that the nanobody is primarily concentrated in the kidneys, bladder, and MM.1S and Ramos or H929 tumors (CD38+). Additionally, the cold antibody NB381 significantly inhibits the uptake of 68Ga-NB381 in tumors, confirming the high specificity of this nanobody's binding to the CD38 protein.
| Study group | Role | What they receive |
|---|---|---|
| Head to head PET imaging comparison between 18F-FDG and 68Ga-NB381 for MM diagnosis | Experimental | 1. 68Ga-NB381 PET/CT Examination: The patient will be intravenously injected with prepared and quality-controlled 68Ga-NB381 (0.05-0.1 mCi/kg). Two hours post-injection, a full-body scan will be conducted using the Shanghai United Imaging uMI 780 PET/CT, covering from the top of the head to the mid-thigh. If indeterminate lesions are identified in routine imaging, delayed imaging will be performed for further evaluation. The patient should lie in a supine position and breathe calmly. Data will be reconstructed using the OSEM method to obtain coronal, sagittal, and transverse PET and PET/CT fused images.
2. 18F-FDG PET/CT Examination: Patients must fast for more than 6 hours before the examination. 18F-FDG (0.05-0.1 mCi/kg) will be administered intravenously, and one hour later. Same requirement as mentioned above. Receives: Drug: 68Ga-NB381 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors
Evaluate the specificity and binding efficiency of 68Ga-labeled NB381 nanobody in targeting CD38 positive tumors using PET imaging. The measure involves comparing the uptake of 68Ga-NB381 in CD38 positive tumors to non-target areas and assessing the ability of cold antibody NB381 to inhibit this uptake, thus confirming the high specificity of the nanobody for CD38 protein.
Measured: For a single patient, imaging and analysis will be conducted within 24 hours post-injection; follow-up assessments for stability and biodistribution will be conducted at 1 week post-injection.
Baseline Pathological Characteristics: Histopathology, Flow Cytometry, and Immunohistochemistry
Baseline bone marrow pathological assessments will be performed, including: (1) histopathological evaluation of plasma cell infiltration; (2) flow cytometry to quantify the proportion of malignant plasma cells and CD38-positive cells; and (3) immunohistochemical profiling for relevant markers (e.g., CD138, κ/λ light chain restriction). Results will be summarized descriptively for baseline disease characterization.
Measured: Baseline (within 28 days prior to first dose of study intervention)
Secondary outcomes (3)
Baseline Disease Characterization: International Staging System (ISS) Stage and Immunofixation Electrophoresis (IFE) Type
Baseline disease characteristics of enrolled participants will be documented, including: (1) International Staging System (ISS) stage (I, II, or III), determined by serum β2-microglobulin and albumin levels per International Myeloma Working Group (IMWG) criteria; and (2) Immunofixation electrophoresis (IFE) type identifying the monoclonal protein isotype (e.g., IgG κ, IgG λ, IgA κ, IgA λ, IgD, free light chain-only, or non-secretory disease). These baseline stratification factors will be summarized descriptively and may be used for pre-specified subgroup analyses to evaluate treatment effect consistency across disease risk profiles.
Measured: Baseline (within 28 days prior to first dose of study intervention)
Baseline Laboratory Assessments: Hematology, Clinical Chemistry, and Myeloma-Specific Biomarkers
Baseline laboratory parameters will be collected, including complete blood count, clinical chemistry (renal/hepatic function, electrolytes, LDH), serum immunoglobulins, serum and urine M-protein quantification, serum free light chains with κ/λ ratio, and urine immunofixation electrophoresis. Results will be summarized descriptively and may be used for baseline characterization and subgroup analyses.
Measured: Baseline (within 28 days prior to first dose of study intervention)
Treatment Response Assessment per IMWG Criteria
Treatment response will be evaluated according to the International Myeloma Working Group (IMWG) consensus criteria, categorizing disease status as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD), or progressive disease (PD). Results will be used to assess preliminary antitumor efficacy.
Measured: End of Cycle 2 (approximately 2 months after first dose) and End of Cycle 4 (approximately 4 months after first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Apr 2024
- Primary completion3 Jun 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging. Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Kang, MD, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385652
- Sponsor's protocol ID
- PekingUFH-MM-NB381
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All case data are anonymized before data analysis; all case files and imaging data are stored in a specialized database, which only the principal investigator is authorized to access and read; all researchers must not disclose any information about any patient.
Publications
Kang L, Jiang D, England CG, Barnhart TE, Yu B, Rosenkrans ZT, Wang R, Engle JW, Xu X, Huang P, Cai W. ImmunoPET imaging of CD38 in murine lymphoma models using 89Zr-labeled daratumumab. Eur J Nucl Med Mol Imaging. 2018 Jul;45(8):1372-1381. doi: 10.1007/s00259-018-3941-3. Epub 2018 Feb 15.
PubMed 29450576Kang L, Li C, Rosenkrans ZT, Huo N, Chen Z, Ehlerding EB, Huo Y, Ferreira CA, Barnhart TE, Engle JW, Wang R, Jiang D, Xu X, Cai W. CD38-Targeted Theranostics of Lymphoma with 89Zr/177Lu-Labeled Daratumumab. Adv Sci (Weinh). 2021 Mar 15;8(10):2001879. doi: 10.1002/advs.202001879. eCollection 2021 May.
PubMed 34026426Kang L, Li C, Yang Q, Sutherlin L, Wang L, Chen Z, Becker KV, Huo N, Qiu Y, Engle JW, Wang R, He C, Jiang D, Xu X, Cai W. 64Cu-labeled daratumumab F(ab')2 fragment enables early visualization of CD38-positive lymphoma. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1470-1481. doi: 10.1007/s00259-021-05593-9. Epub 2021 Oct 22.
PubMed 34677626Kang L, Li C, Rosenkrans ZT, Engle JW, Wang R, Jiang D, Xu X, Cai W. Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. J Nucl Med. 2021 Mar;62(3):372-378. doi: 10.2967/jnumed.120.246595. Epub 2020 Aug 21.
PubMed 32826320
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical PET Imaging Evaluation of 68Ga-NB381 Probe in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06385652
- Acronym / sponsor ID
- PekingUFH-MM-NB381
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.
Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies.
Detailed description
Multiple myeloma (MM) commonly occurs in the elderly and often remains undetected until it reaches an advanced stage. With the aging population in China, the incidence of MM is on the rise, now surpassing that of acute leukemia. Clinically, MM is characterized by bone destruction and lacks specificity; diagnosis primarily relies on bone marrow biopsies that detect an increase in clonal plasma cells, which are invasive and can yield false-negative results if the biopsy site is improperly selected. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for MM.
As the incidence of malignant tumors in China continues to increase, so does the clinical demand for radiopharmaceuticals. Addressing the limitations in the targeting of 18F-FDG in PET imaging, the development of new targeted nuclear medicine molecular probes is of significant academic value and clinical importance, particularly in monitoring the therapeutic effects of the CD38-targeted nanobody NB381, which offers unique advantages. This project uses a nanobody with high affinity for CD38 as the targeting moiety for the radiopharmaceutical, exploring the diagnostic efficiency of 68Ga-NB381 in patients with MM exhibiting high CD38 expression. This not only provides a basis for the early diagnosis of MM but also allows for the formulation of effective precision treatment strategies based on the CD38 expression profile in MM patients.
68Ga-NB381, a new CD38-targeted molecular probe labeled with 68Ga, can be used for the diagnosis and research of various malignancies expressing high levels of CD38, including MM. The probe is conjugated with 68Ga3+ using TOHP as a bifunctional chelator, with a simple labeling process that does not require purification, offering high in-vivo stability and significant radioactive accumulation in tumor sites in mouse models, resulting in superior imaging outcomes. This project will complete the automation of the 68Ga-NB381 labeling process and conduct quality control studies on the resulting radiopharmaceutical injection solution, establishing quality standards for this new PET probe and laying the foundation for its clinical translation in China. The project aims to provide 68Ga-NB381 PET/CT imaging studies to support the early diagnosis of CD38 high-expression malignancies, the formulation of treatment plans, and the assessment of therapeutic efficacy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging. Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition.
| Arm | Type | Receives |
|---|---|---|
| Head to head PET imaging comparison between 18F-FDG and 68Ga-NB381 for MM diagnosis | Experimental | Drug: 68Ga-NB3811. 68Ga-NB381 PET/CT Examination: The patient will be intravenously injected with prepared and quality-controlled 68Ga-NB381 (0.05-0.1 mCi/kg). Two hours post-injection, a full-body scan will be conducted using the Shanghai United Imaging uMI 780 PET/CT, covering from the top of the head to the mid-thigh. If indeterminate lesions are identified in routine imaging, delayed imaging will be performed for further evaluation. The patient should lie in a supine position and breathe calmly. Data will be reconstructed using the OSEM method to obtain coronal, sagittal, and transverse PET and PET/CT fused images. 2. 18F-FDG PET/CT Examination: Patients must fast for more than 6 hours before the examination. 18F-FDG (0.05-0.1 mCi/kg) will be administered intravenously, and one hour later. Same requirement as mentioned above. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suspected of multiple myeloma who are scheduled to undergo bone marrow aspiration or tissue biopsy within the next 3 months; aged between 18 and 90 years; participants must fully understand and voluntarily participate in this study, and sign an informed consent form; must be able to independently comply with the examination procedures.
- Confirmed symptomatic multiple myeloma patients; aged over 18 years; participants must fully understand and voluntarily participate in this study, and sign an informed consent form; must be able to independently comply with the examination procedures.
Key exclusion criteria (2 listed)
- Pregnant women
- Individuals who cannot understand the examination process or are unable to cooperate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NB381Also: 18F-FDGLei Kang from Peking University First Hospital and Bing Jia's team from the School of Basic Medical Sciences at Peking University have developed a targeted CD38 nanobody sequence using genetic engineering technology. They have optimized its structure, functionalized it with labeling, and conducted imaging and other evaluations, ultimately producing the CD38-targeted nuclear medicine small molecule diagnostic and therapeutic agent-68Ga-labeled nanobody NB381. The post-labeling quality control of the drug meets clinical trial requirements with a radiochemical purity (PCR) greater than 98% and in vitro stability not less than 90%. Preliminary PET imaging results of 68Ga-NB381 indicate that the nanobody is primarily concentrated in the kidneys, bladder, and MM.1S and Ramos or H929 tumors (CD38+). Additionally, the cold antibody NB381 significantly inhibits the uptake of 68Ga-NB381 in tumors, confirming the high specificity of this nanobody's binding to the CD38 protein. | Drug | Head to head PET imaging comparison between 18F-FDG and 68Ga-NB381 for MM diagnosis |
Primary outcome
Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors
Time frame: For a single patient, imaging and analysis will be conducted within 24 hours post-injection; follow-up assessments for stability and biodistribution will be conducted at 1 week post-injection.
Evaluate the specificity and binding efficiency of 68Ga-labeled NB381 nanobody in targeting CD38 positive tumors using PET imaging. The measure involves comparing the uptake of 68Ga-NB381 in CD38 positive tumors to non-target areas and assessing the ability of cold antibody NB381 to inhibit this uptake, thus confirming the high specificity of the nanobody for CD38 protein.
Baseline Pathological Characteristics: Histopathology, Flow Cytometry, and Immunohistochemistry
Time frame: Baseline (within 28 days prior to first dose of study intervention)
Baseline bone marrow pathological assessments will be performed, including: (1) histopathological evaluation of plasma cell infiltration; (2) flow cytometry to quantify the proportion of malignant plasma cells and CD38-positive cells; and (3) immunohistochemical profiling for relevant markers (e.g., CD138, κ/λ light chain restriction). Results will be summarized descriptively for baseline disease characterization.
3 secondary outcomes
Baseline Disease Characterization: International Staging System (ISS) Stage and Immunofixation Electrophoresis (IFE) Type
Time frame: Baseline (within 28 days prior to first dose of study intervention)
Baseline Laboratory Assessments: Hematology, Clinical Chemistry, and Myeloma-Specific Biomarkers
Time frame: Baseline (within 28 days prior to first dose of study intervention)
Treatment Response Assessment per IMWG Criteria
Time frame: End of Cycle 2 (approximately 2 months after first dose) and End of Cycle 4 (approximately 4 months after first dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 29450576Kang L, Jiang D, England CG, Barnhart TE, Yu B, Rosenkrans ZT, Wang R, Engle JW, Xu X, Huang P, Cai W. ImmunoPET imaging of CD38 in murine lymphoma models using 89Zr-labeled daratumumab. Eur J Nucl Med Mol Imaging. 2018 Jul;45(8):1372-1381. doi: 10.1007/s00259-018-3941-3. Epub 2018 Feb 15.
- Background: PubMed 34026426Kang L, Li C, Rosenkrans ZT, Huo N, Chen Z, Ehlerding EB, Huo Y, Ferreira CA, Barnhart TE, Engle JW, Wang R, Jiang D, Xu X, Cai W. CD38-Targeted Theranostics of Lymphoma with 89Zr/177Lu-Labeled Daratumumab. Adv Sci (Weinh). 2021 Mar 15;8(10):2001879. doi: 10.1002/advs.202001879. eCollection 2021 May.
- Results publication: PubMed 34677626Kang L, Li C, Yang Q, Sutherlin L, Wang L, Chen Z, Becker KV, Huo N, Qiu Y, Engle JW, Wang R, He C, Jiang D, Xu X, Cai W. 64Cu-labeled daratumumab F(ab')2 fragment enables early visualization of CD38-positive lymphoma. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1470-1481. doi: 10.1007/s00259-021-05593-9. Epub 2021 Oct 22.
- Results publication: PubMed 32826320Kang L, Li C, Rosenkrans ZT, Engle JW, Wang R, Jiang D, Xu X, Cai W. Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. J Nucl Med. 2021 Mar;62(3):372-378. doi: 10.2967/jnumed.120.246595. Epub 2020 Aug 21.
- Individual participant dataSharing planned: No. All case data are anonymized before data analysis; all case files and imaging data are stored in a specialized database, which only the principal investigator is authorized to access and read; all researchers must not disclose any information about any patient.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Kang, MD study director
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-NB381 in people with Multiple Myeloma, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TIANYAO Wang, PhD (+8613439014669, tianyao.wang@pkufh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors (time frame: For a single patient, imaging and analysis will be conducted within 24 hours post-injection; follow-up assessments for stability and biodistribution will be conducted at 1 week post-injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06385652, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.